Posted by Michael Wonder on 06 Apr 2017
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
6 April 2017 - The U.S. FDA today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions.
These are the first direct-to-consumer tests authorised by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The genetic health risk tests are intended to provide genetic risk information to consumers, but the tests cannot determine a person’s overall risk of developing a disease or condition. In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors.
